Devices

CDRH Steps Up Enforcement Against Zika Tests

CDRH is escalating its enforcement against laboratory-developed tests being marketed for Zika virus detection. Last week, the Center sent a letter to MD Biosciences challenging its marketing of the Zika Virus RNA by RTPCR Assay (see story). Now, the agency has sent two additional letters — one to First Diagnostic Corp. and a joint letter to Houston Methodist Hospital and Texas Children’s Hospital.

In the letter to First Diagnostic, CDRH questions the ATFirst’s One Step Zika Antibody Test, which is intended “for the simultaneous detection and differentiation of lgG and lgM antibodies to Zika Virus in human serum, plasma or whole blood.” It says that in light of the current public health emergency, “it is particularly important for the FDA to review information related to your ATFirst's One Step Zika Antibody Test’s design, validation, and performance characteristics.”

And in the letter to the hospitals, the Center questions their marketing of the Zika Direct Test, which is intended to be used as a rapid diagnostic test to identify virus-specific RNA sequences to directly detect Zika virus. “The FDA would like to better understand the test's design, validation and performance characteristics, and in addition, CDC and CMS have asked us to review the science behind your test,” the letter says. It also asked to review information related to the test’s development.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome